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Volumn 34, Issue 4, 2011, Pages 299-305

Individual case safety reports how to determine the onset date of an adverse reaction: A survey

Author keywords

Adverse drug reactions; Adverse reaction monitoring; Legislation; Pharmacovigilance; Postmarketing surveillance; Questionnaires.

Indexed keywords

HERBACEOUS AGENT;

EID: 79952773341     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11588490-000000000-00000     Document Type: Article
Times cited : (7)

References (14)
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    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat Oct [online] [Accessed 2011 Jan 21]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical safety data management: definitions and standards for expedited reporting E2A. Geneva: ICH Secretariat, 2004, Oct [online]. Available from URL:http:// www.ich.org/products/guidelines/ efficacy/article/efficacyguidelines.html [Accessed 2011 Jan 21].
    • (2004) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A
  • 2
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    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat Nov [online] [Accessed 2011 Jan 21]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Post-approval safety data management: definitions and standards for expedited reporting E2D. Geneva: ICH Secretariat 2003 Nov [online]. Available from URL: http://www.ich.org/products/ guidelines/efficacy/ article/efficacy-guidelines.html [Accessed 2011 Jan 21].
    • (2003) Post-approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D
  • 4
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    • US Department of Health and Human Services, Food and Drug Administration [Accessed 2011 Jan 21]
    • US Department of Health and Human Services, Food and Drug Administration. Form voluntary reporting (form FDA 3500) [online]. Available from URL: http://www.fda. gov/Safety/MedWatch/HowToReport/DownloadForms/de fault.htm [Accessed 2011 Jan 21].
    • Form Voluntary Reporting (Form FDA 3500)
  • 5
    • 79952752946 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration [Accessed 2011 Jan 21]
    • US Department of Health and Human Services, Food and Drug Administration. Form mandatory reporting (form FDA 3500A) [online]. Available from URL: http://www. fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ default.htm [Accessed 2011 Jan 21].
    • Form Mandatory Reporting (Form FDA 3500A)
  • 6
    • 79952751718 scopus 로고    scopus 로고
    • Council for International Organizations ofMedical Sciences [online] [Accessed 2011 Jan 21]
    • Council for International Organizations ofMedical Sciences [online]. Available from URL: http://www.cioms.ch/form/ frame-form.htm [Accessed 2011 Jan 21].
  • 7
    • 84876541542 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration [Accessed 2011 Jan 21]
    • US Department of Health and Human Services, Food and Drug Administration. Vaccine Adverse Event Reporting System (VAERS) [online]. Available from URL: https:// vaers.hhs.gov/esub/index [Accessed 2011 Jan 21].
    • Vaccine Adverse Event Reporting System (VAERS) [Online]
  • 8
    • 79952766542 scopus 로고    scopus 로고
    • Public Health Agency of Canada [Accessed 2011 Jan 21]
    • Public Health Agency of Canada. Adverse events following immunization reporting form [online]. Available from URL: http://www.phac-aspc.gc.ca/im/aefi- form-eng.php [Accessed 2011 Jan 21].
    • Adverse Events Following Immunization Reporting Form [Online]
  • 9
    • 79952747304 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat May [online] [Accessed 2011 Jan 21]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Revision of the ICH guideline on clinical safety data management data element for transmission of individual safety reports E2B (R2). Geneva: ICH Secretariat, 2005 May [online]. Available from URL: http:// www.ich.org/products/guidelines/efficacy/article/ efficacyguidelines.html [Accessed 2011 Jan 21].
    • (2005) Revision of the ICH Guideline on Clinical Safety Data Management Data Element for Transmission of Individual Safety Reports E2B (R2)
  • 10
    • 0003671241 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Food and Drug Administration [Accessed 2011 Jan 21]
    • Center for Drug Evaluation and Research, Food and Drug Administration. The clinical impact of adverse event reporting [online]. Available from URL:http://www.fda. gov/downloads/Safety/MedWatch/UCM168505.pdf [Accessed 2011 Jan 21].
    • The Clinical Impact of Adverse Event Reporting [Online]
  • 12
    • 79952749487 scopus 로고    scopus 로고
    • US FDA [Accessed 2011 Jan 21]
    • US FDA. Patient profile viewer: notice of pilot project [online]. Available from URL: http://www.federalregister. gov/articles/2001/12/10/01- 30430/patient-profile-viewer-no tice-of-pilot-project [Accessed 2011 Jan 21].
    • Patient Profile Viewer: Notice of Pilot Project [Online]
  • 13
    • 78649659736 scopus 로고    scopus 로고
    • Postmarketing safety surveillance: Issues with data collection for postmarketing pharmacovigilance
    • Edwards B, Prabhakar U. Postmarketing safety surveillance: issues with data collection for postmarketing pharmacovigilance. Pharm Med 2010; 24 (6): 1-6.
    • (2010) Pharm Med , vol.24 , Issue.6 , pp. 1-6
    • Edwards, B.1    Prabhakar, U.2
  • 14
    • 79952760656 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva: ICH Secretariat Aug [online] [Accessed 2011 Jan 21]
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical development Q8 (R2). Geneva: ICH Secretariat 2009 Aug [online]. Available from URL: http://www.ich.org/products/guidelines/quality/article/ quality-guidelines.html [Accessed 2011 Jan 21]
    • (2009) Pharmaceutical Development Q8 (R2)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.